Corticosteroids

to reduce the incidence of respiratory distress

Prevention

GLOBAL ANNUAL DEATHS ASSOCIATED WITH NEONATAL RESPIRATORY DISTRESS

PERCENT (%)

NUMBER

Maternal

N/A

N/A

Neonatal

20-25%

765,000

Stillbirth

N/A

N/A

Condition

Infant respiratory distress syndrome (RDS) occurs in 40-50% of neonates born prior to 32 weeks. RDS is caused by structural immaturity of the lungs and insufficient surfactant production. Corticosteroids can accelerate lung maturation, decreasing the severity or preventing RDS. Corticosteroids (more specifically glucocorticoids) are frequently given antenatally to women at risk of preterm delivery. This often reduces the treatment the preterm infant will require to survive at birth.

Mechanism of Action
Corticosteroids (specifically betamethasone or dexamethasone) administered to a gravid woman cross the placenta to promote accelerated fetal lung maturation and production of surfactant. Corticosteroids may be administered intramuscularly at 28-36 weeks of gestation in gravid women who show signs they may deliver preterm. In order for this treatment to be most effective, delivery should not occur for 24-48 hours after the drug is administered. Betamethasone has been used for decades and is the preferred corticosteroid for this function. Two doses of 12mg are recommended intramuscularly, 24 hours apart.

Current use in High-Resource Settings
Corticosteroids are not currently labeled for use in preterm labor in the US; however, coricosteroids are commonly used for preterm delivery. Given the relatively low cost and ease of administration, increased penetration is limited by the ability to quickly diagnose an at-risk fetus. Cost savings associated with the avoidance of surfactant and respiratory support are substantial.

Application in Low-Resource Settings
Where surfactant and ventilation are less likely to be available, corticosteroid use has the potential to save lives. In facility settings and among skilled attendants, intramuscular injection is feasible. There are ongoing efforts to pre-load betamethasone into the Uniject device in order to further reduce the skill required for administration. This could expand the base of end users, but is not yet commercially available. Corticosteroid therapy is not advised for women who have systemic infections such as tuberculosis. Caregivers in regions with high prevalence of infectious disease must be more cautious before administration of this drug.

REPRESENTATIVE DEVICES

MAKE

MODEL

PRICE*

TECH

STATUS

NOTES

Schering-Plough

Celestone Soluspan

$50

2, 12 mg injections

Marketed

Branded product at premium

Generic

Dexamethasone

$12

2, 6 mg injections

Marketed

Generics widely available

* Prices are approximated. Actual pricing can, and will vary by marketplace and market conditions.

CHARACTERISTICS OF REPRESENTATIVE PRODUCT

TECHNOLOGY CHARACTERISTICS

OPERATIONAL PARAMETERS

POTENTIAL OPPORTUNITIES FOR IMPROVEMENT

SKILLS

REQUIRED

Intended end user

Training required

Time required per use

Physician, nurse

Hours

Minutes

Correct and timely diagnosis is a major barrier where gestational age is unknown. The availability of trained staff is crucial to effective administration.

ENVIRONMENT/ INFRASTRUCTURE

Power required

Waste collection

Complementary technologies required

Temperature and storage

Maintenance

None

Sharps

Syringe (or Uniject)

Store vial at 25ºC; excursions permitted15-30ºC. Protect from light.

None

Timing is a critical factor, since the largest benefit occurs with administration 24-48
hours prior to delivery.

COST

Device Cost (Approx)

Cost/course (Approx)

$1-$35

$1-$35

OTHER

Portability

Regulatory

Efficacy

<10g

Uniject not yet approved

Unknown for environments where advanced neonatal care is unavailable.

Additional devices and procedures required for impact: A way to identify women in preterm labor (e.g. a method to measure fundal height and a gestational age wheel); a sufficient infrastructure to support common complications of pre-term infants, a way to prolong labor such as the drug ritodrine.